ITAC
Trial question
What is the role of hyperimmune IVIG in patients hospitalized with COVID-19?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 579
579 patients (250 female, 329 male)
Inclusion criteria: hospitalized patients with symptomatic COVID-19
Key exclusion criteria: previous passive immunotherapies; end-organ failure; known IgA deficiency with anti-IgA antibodies; certain thrombotic conditions and prothrombotic disorders
Interventions
N=295 hyperimmune IVIG (single infusion of 400 mg/kg of hyperimmune immunoglobulin to COVID-19 plus remdesivir)
N=284 placebo (a single infusion of saline plus remdesivir)
Primary outcome
Patients with favorable clinical categories 1 and 2
60
56
60.0 %
45.0 %
30.0 %
15.0 %
0.0 %
Hyperimmune intravenous
immunoglobulin
Placebo
No significant
difference ↔
No significant difference in patients with favorable clinical categories 1 and 2 (60% vs. 56%; RRR 1.11, 95% CI 0.91 to 1.35)
Secondary outcomes
No significant difference in patients who were discharged or with favorable clinical category 1 (91% vs. 89%; RRR 1.07, 95% CI 0.92 to 1.26)
No significant difference in death at day 28 (6% vs. 8%; HR 0.8, 95% CI 0.42 to 1.51)
Safety outcomes
No significant differences in patients with composite safety outcome of death, serious adverse effects and infections at day 28.
Significant difference in infusion reactions (18.6% vs. 9.5%).
Conclusion
In hospitalized patients with symptomatic COVID-19, hyperimmune IVIG was not superior to placebo with respect to patients with favorable clinical categories 1 and 2.
Reference
ITAC (INSIGHT ) Study Group. Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial. Lancet. 2022 Feb 5;399(10324):530-540.
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